Breakthrough or Tease?

Dr. Denise Faustman, a researcher at Massachusetts General Hospital in Boston who runs a lab focused on finding a cure for Type 1 diabetes, is no stranger to controversy — as we noted three years ago in an interview she gave for Diabetes Flashpoints. When her lab discovered in 2001 that a treatment for mice with diabetes could restore lost beta cell function, the editors of a scientific journal wouldn’t let her use the word “regeneration” because of the shock it might cause. And now, with the release of results from her first human trials, the scientific and wider diabetes community still seems to be sharply divided by her work.

Last week in the online journal PLOS ONE, Faustman’s team revealed the results of a small “proof-of-concept” trial that tested their approach to research in humans for the first time. As an article at DiabetesInControl.com notes, the study tested whether a drug known as BCG, used as a vaccine for tuberculosis since 1921, had any effect on measures of autoimmunity and insulin production in people with long-term Type 1 diabetes. Of the study’s six primary participants, three were randomly assigned to receive injections of BCG, while three received placebo (inactive) injections. The effects of BCG in the participants with Type 1 diabetes were also compared against those seen in people without diabetes, who were also given the drug and monitored as part of the study.

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The scientists discovered that a greater number of autoimmune T cells — the immune system cells that attack the pancreas in Type 1 diabetes — were found to be dead in participants with Type 1 diabetes who received BCG for about a week following each injection. One participant who received placebo injections also saw this increase in dead autoimmune T cells, but he was found to have been infected with a virus at the time that is known to raise levels of a compound in the body called tumor necrosis factor. BCG also raises levels of this compound, which is believed to be related to the death of autoimmune T cells. Participants who received BCG, as well as the one with the viral infection, also showed signs of greater insulin production by the body’s own pancreas (although insulin production was not measured directly, since it couldn’t be distinguished from injected insulin in the lab’s measurements).

As quoted in the DiabetesInControl.com article, Dr. Faustman hailed the results as “early evidence of effectiveness” at reversing autoimmunity with BCG. Another scientist, however, who was not involved in the study, denounced using BCG to reverse autoimmunity as “wishful thinking” and noted that its use for this purpose has been tested before, to no avail. He also noted that Dr. Faustman’s study showed only short-term improvement “in a couple of patients” — while the chief executive of JDRF, the Type 1 diabetes research organization, called Faustman’s results “certainly interesting and worth further investigation,” which is already under way in a larger study with hundreds of participants.

What do you think — does Faustman’s approach sound promising to you? Does it seem too good to be true that a 90-year-old drug could restore insulin production in people with Type 1 diabetes? Should Faustman’s lab receive funding from JDRF or the National Institutes of Health rather than relying on private donations? Should pharmaceutical companies help fund studies like this one, even though the drug being tested is already on the market with no patent (and therefore couldn’t bring large profits to any company)? Leave a comment below!

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Virginia

The thought of the possibility of this “old” drug being able to reverse Type 1 diabetes is fantastic.
I have had Type 1 for 57 years, with NO complications. The amount of insulin I take via pump is miniscule (17-19 units per day), compared to the amount the healthy human body produces on its own. To me this indicates I am producing some insulin in my own body. The thought that this drug could prod my pancreas to produce more is very hopeful.
Please continue the research. Your efforts are an answer to my prayers.
Thank you.

Gary

I would love to see a drug to prod my Pancreas..
I have been a type 1 diabetic for several years and useing several units of humulog daily as well as lantus daily.. And have a lot of complications and out of control numbers. So I would love to see any help for us diabetics.
Thank you,

Kris

I have had type 1 for almost 40 years and am starting to run into complications. I’d love to see something available at a reasonable price that could help. I’m not a reasearcher but why couldn’t something like this work? Just dismissing it without giving it a chance seems short-sighted.

I’ve followed this particular research group with much interest for the last several years. I would hope that groups like the JRDF would show intrest and perhaps whelp with funding. Unfortunately, I’m sure that the pharmacuetical companies won’t want this to happen – they can’t make a ton of money from it and it would ultimately take away from their insulin sales. Too much downside for them.

Hopefully others who are more interested in actually helping the people with type 1 find a cure will step up and help with funding.

Joe Barta

I do not trust comments made by people such as Mr. “Wishful Thinking” as a valid remark without knowing their name and credentials. As a scientist I think any possibly of such a drug should be followed up and naysayers should be willing to be identified so that they can get credit in the future for their wisdom or scientific insight.

jim snell

Oh boy; this is an interesting thread.

From where I sit I see:

a) something previously missed has been walked over and some curious data surfaced.

b) probably more research is needed to identify whether we are looking at the edge of the issue and discovered some mechanics or whether we are on the main effect. It may be this is one step/issue with others that later evolved will lead to some successfull important results.

c) there is not sufficient data to arrive at any firm conclusion for this outsider not really involved in the research.

d) even metformin required a couple of passes to come up with the right least toxic form that is now used everywhere.

e) this is typical science/research where many main leads have to be walked down to isolate the key factors and arrive at a practical solution.

Sue

What I think is that I will not consider an opinion by an unknown “scientist who was not involved in the study” unless he/she comes out of anonymity. Faustman has been clear that this is a VERY preliminary finding. All “proof-of-concept” means is that there is enough reason generated to pursue further study. That’s all. And again, she has been VERY VERY clear about that. I don’t care how it’s funded, as long as it’s funded.

This is good news. However, research in T1 has provided much good news before and some of it becomes a tangible treatment possibility, some doesn’t. ALL of it has value in the process though. This is what research is. It irritates me when the press/people spin it in a way that it wasn’t intended. The really amazing part of this particular study is that she is looking at a group that no one else is looking at…most research is being done on newly diagnosed T1 subjects who have some pancreatic activity. Research based on this proof-of-concept could lead to help for those who have been fighting this fight for a long time.

B D

1st. The age of the drug means nothing. It has no meaning if the drug is 1000 or 10 years old.

2nd. the JDRF in the past has wanted nothing to do with her research. They have in the past said they will not give her a research grant. That is why she relies on private donations.

3rd. She tried to get pharmaceutical companies to help her make a drug that would do what she needed. They turned her down. Stating they make more money as it stands. So no help there.

This is why she is doing they way she is, and has for a decade.

Nicola

I think any plausible possibility that can reverse Type 1 has to be followed up. My son (aged 4) developed Type 1 with no genetic history and it is on the rise in the under 5s. I think Dr Fraustman needs money to help fund this valuable research and follow up on these leads. I think it is tricky situation as to where the funds come from – not in the interest of the pharma companies who make revenue from the testing strips etc. Why would they invest to reduce their profits? Doesn’t make business sense. In the UK the poor NHS has a huge burden, all the prescriptions, clinic appts and hospital stays, plus hospital care for possible future complications (so pleased to hear Virginia is 57yrs with no complications!) that diabetes alone could cripple the NHS. Therefore i think it is the government who could contribute to such research. It is in their interest to rid us of this terrible afflication which an individual did not bring upon themselves.
I would gladly pay more NI or more petrol duty if that money was used to fund research such as this.

Mary

If the JDRF and the pharmaceutical companies won’t help her, than the NIF should feel obligated to fund the research. JDRF has lost may donation dollars since I learned of Dr. Faustman’s work.
Let’s not forget that this drug is capable of helping countless people with other auto-immune diseases.

Mary

If the JDRF and the pharmaceutical companies won’t help her, than the NIF should feel obligated to fund the research. JDRF has lost my donation dollars since I learned of Dr. Faustman’s work.
Let’s not forget that this drug is capable of helping countless people with other auto-immune diseases.

margot

I do think that JDRF should aid in research funding, as well as the National Institute of Health. With more funding, outcomes can be discovered sooner. It’s possible that more investigation will lead to new questions and new possibilities, so it seems worthwhile to support.

As far as financial support from pharmaceuticals, I don’t know. It seems like a reversal of a disease like type I diabetes has the potential to cost pharma lots of revenue. I don’t have faith in many pharmaceutical companies, and I am unsure of what their financial involvement could do to the scientific process in this study.

Steve Kane

Dr Faustman is a very brave and lonely researcher. She could be making big bucks in private industry, or going after huge grants to study whatever flavor-of-the-month the NIH is chasing at that time. Instead she is determined to prove her exciting theses, and thru processes that even the NE Journal of Medicine have to recognize as valid studies. Our entire system is biased against her — using a public domain molecule for new purposes? Heresy! Questioning the universally held scientific belief that Type 1 people have permanently lost the ability to produce insulin? Lunacy!

Diabetics and non-diabetics alike, we should all pray for more Faustmans. True revolutions come from lonely brave visionaries, determined to ignore the naysayers.

The establishment reaction to Faustman’s work is a perfect example of why we should all recoil from and reject the noxious but increasingly relied upon term, “scientific consensus.” Science is repeatable experiments. Not consensus. The establishment has done almost nothing in the way of therapies and treatments for diabetes since insulin. A little radical thinking may be just what the doctor needs to order?

Rip Singh

Dr.Faustman’s research has shown promising results and definitely deserves national health/ federal funding to determine exact outcomes in humans.

As you have pointed out, not sure what position Big Pharma will have on this research as it promises no big profits for them. Infact, they probably stand to lose if a “true & full” cure is finally found.

While I have supported JDRF’s efforts for the last 8 years, am a little disappointed with JDRF’s stand on Dr. Faustman’s research. This research has a common purpose and JDRF should definitely be supporting, if not outright collaborating with Dr. Faustman on finding a cure (and vice versa). I hope JDRF is still focussed on this single purpose objective – their executives and employees will still have jobs preventing future diabetics after a CURE is found!

We definitely hope & wish that JDRF, Dr. Faustman and other CURE seekers combine and collaborate to rid the world of this debilitating disorder. C’mon guys you can do it!

Donna McCarthy

I have been a type 1 diabetic for 27 years and have retinopathy in my right eye that is being treated. My husband and I flew from Idaho to Boston to participate in Dr Faustman’s research. She is my hope. If I have to have a BCG vaccine a couple or a few times a year, that beats taking insulin shots 4-5 times a day!! Yes, I hope that she gets funding from the JDRF! It’s time for a cure or if anything a better way to treat the disease!

Donna from Idaho

Rosalie

Absolutely this would not surprise me at all. The cure has always been there – we just haven’t stumbled on it yet. We will, and I think the major players know it, which is why the maintenance drugs and therapies are being fast-tracked through the FDA as we wait. Once the big drug companies have covered their costs, then the cure will be allowed to surface. And shame on the JDRF for not funding for a cure instead of funding the maintenance of the disease.

Amy Cook

Yes, Dr. Faustman’s lab should recieve funding from JDRF! My 6 year old has had type 1 for 3 years, and it is our family’s dream to see this aweful disease cured. We are getting ready to participate in our 3rd JDRF Walk to Cure Diabetes and we would love to see this organization support this research.

Diana sari

Sure! Dr. Denise and her team got my full support to continue the research. Please dont always think about profit. This is for the sake of so many human being, diabetics person, friends and family. It could be on your family and loved ones too… So, I think all people should giving full support to the research.

kim liddy

Yes, I would love to see JDRF get involved with Dr. Faustman! They have the funds to help. We have been big advocates of Jdrf since our son was diagnosed almost 5 yrs. ago. We found Dr. Faustman’s information about 4yrs.ago. It seems that Dr. Faustman’s trials could be moving along quicker if she had the funding. Please collaborate for the better good of our children, who we so desprately hate to see dealing with type 1 and its many gruling effect. Our children are waiting for this and there is hope. Let’s take the chance and make it happen. Give this a chance. Jdrf does wonderful things like the articial pump which will improve the lives of type 1’s, but again it is not a cure. The diabetic community and the world would be estatic to see jdrf make this commitment to make history. To hear that anyone would care if pharmacuticals are making enough money when it compares to human life is insulting. When tiny vials of insulin are over $100 a bottle and test strips are over $1.00 a strip. They don’t even make glucose gel or glucose shot (juice) reasonably priced. At $4 and $2 respectively to cure a one time low. What about all those people in third world countries that are dying because they can’t get access to insulin. Please join forces to help Dr. Faustman!

cheryl

I have type 1 and I was 25 when I got it. My doctor was the top diabetes doctor in Kansas, he told me to think up because the cure was right around the corner. I am 55 now and I dont get too excited when I hear of any study. I wore a pump for a few months and it almost killed me. I had some bad tubing that they recalled. I looked at the box’s I had and all of the serial no’s were the recalled ones. Made in costa rica! I wouldn’t put it back on. Meditronic.

Bill Swanson

I know why Dr Faustman has very little financial support (i.e. none from the medical community, government or large organizations (JDRF for instance): that’s because these sources are funded (or have lobbyists in the case of the Gov) primarily by the companies that do NOT want diabetes cured.

What I truly don’t understand is that if there are anywhere from 1 to 3 million of us type 1 diabetics in the USA alone, why can’t each one of us throw Dr Faustman $5 for her research? I give $25 a month, which I can barely afford… I skip my morning coffee at the coffee shop and make it at home. She’s $10 mil away from the next stage in the development of the BCG cure. Isn’t worth the price of a few lottery tickets to see if she can find it?

Am I trying to be altruistic? Nope. I have type 1 diabetes and it’s ruined the possibilities my life could have taken. So, YES I will throw some money towards the possibility of a cure.

What about you?

Nori Etchells

I pray that the focus is never on how much money this may or may not bring to huge pharmaceutical companies…..but on the huge number of lives it may improve and EXTEND. Especially those of MANY young children.
I agree with post above….to not see this through a little further is very short sighted.

You can certainly shoot holes in ANY research….but I wonder if this research is being ignored largly because there is no “profit” in it’s development. The vaccine is already tried and true for other treatment and it’s inexpensive to produce.
What I have read so far (over the past few years) seems hopeful and valid. I am not a scientist or Dr. but I am a well informed, loving mother of a 13 year old type 1 diabetic. I see quite well how “lucrative” it is to TREAT this disease. I will continue to pray for this research for a CURE.

Shannon Cook

I am 38 and have been living with Type 1 diabetes for 31 years this month. When the article was published in our local paper a few weeks ago I made copies of it and wrote out my story and posted it all around my neighborhood. I am giving a donation with every paycheck my husband and I recieve. I agree with Bill two posts up. We should all be giving just a little and she would have the money she needs to continue the research. Imagining the possibility of life without the complications of diabetes brings me to tears every time I read a new post. I believe the pharmaceutical companies should make donations, not investments, in her research. They have been making money off of our misfortune for a very very long time. Research and find a treatment for something else to make your profits. Don’t get me wrong. I am thankful for the insulin, but it’s been out for decades and it still costs over $100 a bottle. It’s not right, and tests strips. Seriously, how can they charge what they charge? I am so fortunate and thankful to be as healthy as I am and thankful I have the resources to treat my diabetes, but to find a better way…. that is my dream… God bless Dr. Faustman and her team and please help them with their research.

Maria

God Bless Dr. Faustman!!!!

lindagraciela

Highly interesting. BCG is also the drug my uncle is receiving against his bladder cancer, and it has been helping him survive for two years so far. I wish I were a scientist to figure out if there’s a connection between the two actions of BCG.

Jennifer Taylor

I believe it’s time to put pressure on our local investigative news teams to do stories on Dr. Faustman’s research and to examine the possibility that drug companies may be preventing progress in the name of profit.

Sheila Weyrick

We have 3 generation of type 1 in our family tree. My husband’s 80yr old mother, my husband who is 50 has had it since he was 15,and our 11 yr old son who was diagnosed at 3. I think everyone should stop doing walks for other diabetes organizations and start walking or raising money for Dr. Faustman. Great idea by someone earlier, that if everyone that has a loved one with type 1 diabetes sent in $10 a month this research could get funded alot faster.
Plus it is tax deductible.
It is way past time for a cure!!

Steve Hutto, MD

I would recommend sending JDRF a communication complaining about the seeming lack of interest in this research and demanding this research be paid attention to and funded. I would also recommend sending a communication to your local representative and senator to try to get NIH funding for this research.
I personally will pull my funding from JDRF and start donating to Dr. Faustman’s research.
This is scandalous that a disease which a million americans are living with is not being adequately funded regarding potential cures. This may not be the answer, but it may produce a small shred of relevant information which then leads to the cure.
Drug companies will have no interest in this particular research because there is no profit in it for them at this point. I have no problem with that because I think drug companies have developed amazing drugs which have helped many. However, this is what the NIH and other federal research organizations are for.

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